Research and Development Committee SOP 2

North Florida/South Georgia Veterans Health System Research Service

STANDING OPERATING PROCEDURES

Research and Development Committee

February 18, 2010

Contents

1. PURPOSE 2

2. BACKGROUND 2

3. DEFINITIONS 2

4. SCOPE 3

5. RESPONSIBILITIES OF THE NF/SGVHS MEDICAL CENTER DIRECTOR 4

6. RESPONISBILITIES OF THE CHIEF OF STAFF (COS) 5

7. RESPONSIBILITIES OF THE ACOS FOR R&D (ACOS/R&D) 5

8. ADMINISTRATIVE OFFICER FOR R&D (AO/R&D) 6

9. RESPONSIBILITIES OF THE INVESTIGATOR 6

10. RESPONSIBILITIES OF THE R&D COMMITTEE 6

11. R&D COMMITTEE RESPONSIBILITIES FOR THE REVIEW OF RESEARCH 8

12. R&D COMMITTEE OPERATIONS 9

13. R&D COMMITTEE RECORDS 10

14. R&D COMMMITTEE MEMBERSHIP 10

15. SUBCOMMITTEES OF THE R&D COMMITTEE 12

16. CONFLICT OF INTEREST 14

REFERENCES 15

FOLLOW-UP RESPONSIBILITY 16

1.  PURPOSE

1.  These are the Standard Operating Procedures for the North Florida/South Georgia Veterans Health System (NF/SGVHS) Research and Development (R&D) Committee. They are based on the VA (Department of Veterans Affairs) regulations and other applicable federal regulation governing the conduct of local research programs, and the R&D Committee Charter.

2.  The major purpose of the R&D Committee is to focus on oversight of the local research program. The R&D Committee accomplishes its oversight function by assigning scientific review and other administrative responsibilities, including compliance issues, to appropriate subcommittees and Research Service office and individuals. The R&D Committee members prioritize their deliberations around broad areas of program development, risk management, and quality and performance activities.

2.  BACKGROUND

The research mission of the Department of Veterans Affairs (VA) is conducted with individual VA medical centers, such as the NF/SGVHS, according to the highest ethical standards with accountability to all involved stakeholders. Responsibility for oversight and maintaining high standards is assigned to the NF/SGVHS R&D Committee.

3.  DEFINITIONS

1.  VA Data or VA Information. VA data or VA information owned or in the possession of VA or any entity acting for, or on behalf of VA.

2.  VA Research. VA research is research conducted by VA investigators (serving on compensated, work without compensation (WOC), or Intergovernmental Personnel Agreement (IPA) appointments) while on VA time, utilizing VA resources (e.g. equipment), or on VA property including space leased to, or used by VA. The research may be funded by VA, by other sponsors, or be unfunded.

3.  VA Sensitive Information. VA sensitive information is all VA data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information (VA Handbook 6500). The term includes information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, and information that can be withheld under the Freedom of Information Act (FOIA). Examples of VA sensitive information include:

  1. Individually-identifiable medical, benefits, and personnel information;
  2. Financial, budgetary, research, quality assurance, confidential commercial, critical infrastructure, investigatory, and law enforcement information;
  3. Information that is confidential and privileged in litigation, such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney-client privilege; and
  4. Other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of Federal programs.

4.  SCOPE

1.  The NF/SGVHS has established the R&D Committee as its committee of record for oversight of the local VA research Program.

2.  The R&D Committee is responsible, through the Chief of Staff (COS) to the NF/SGVHS Medical Center Director for:

i.  Advising and assisting the NF/SGVHS Medical Center Director in providing oversight, planning, and execution of the local research Program; and

ii.  Assisting the NF/SGVHS Medical Center Director in maintaining high standards throughout the R&D Program. Those standards include ensuring the:

a.  Scientific and ethical quality of VA research projects;

b.  Protection of human subjects in research;

c.  Safety of personnel engaged in research;

d.  Welfare of laboratory animals;

e.  Security of VA data; and

f.  Security of VHA research laboratories.

3.  The R&D Committee is assisted by the Associate Chief of Staff (ACOS) for R&D and the Administrative Officer (AO) for R&D in carrying out its duties.

4.  Research in which the facility is to be engaged may not be undertaken without review and written approval of all appropriate subcommittees of the R&D Committee. The investigator must not initiate a research project until after being notified in writing by the ACOS for R&D that the project has been approved by all relevant committees, subcommittees, or other entities.

  1. The following procedure is followed to assure that each research protocol receives all appropriate subcommittee reviews and approvals and is ready for placement on the R&D Committee’s agenda:
  2. The NF/SGVHS Research Office Grants Administration Core – Human Research Protection Program (HRPP) Office, and Institutional Animal Care and Use Committee (IACUC) Office are responsible for processing all VA protocols and acquiring the appropriate reviews and approvals before presentation to the respective subcommittees (includes Subcommittee on Research Safety (SRS), Institutional Animal Care and Use Committee (IACUC), the Information Security Officer and Privacy Officer), and for submission for final approval by the R&D Committee.
  3. The R&DC subcommittee secretaries must confirm that all studies submitted for the R&DC agenda have been documented in the subcommittee minutes as approved, and provide the meeting date of the approval to the R&DC Secretary. The UF IRB-01 final approval letter must also be in the HRPP Office study file.
  4. The R&D Committee Secretary generates all approval letters prior to the R&DC meeting. All appropriate approval signatures are obtained on the approval letter following the R&DC meeting adjournment.
  5. The R&D Committee Secretary presents the signed approval letters to the ACOS/R&D for his/her signature. The original approval letters and an electronic copy are sent to the investigator. Once R&D Committee approval has been given, and the ACOS/R&D Committee signs the final approval letter the research becomes VA approved research.

5.  RESPONSIBILITIES OF THE NF/SGVHS MEDICAL CENTER DIRECTOR

1.  The NF/SGVHS Medical Center Director, is the Institutional Official, is responsible for:

  1. The Facility’s research program, and is assisted by the R&D Committee. The NF/SGVHS Medical Center Director serves as the Institutional Official responsible for all aspects of research program including but not limited to: human subjects protection, animal welfare care and use, privacy and security of VA data, and biosafety.
  2. Ensuring that all research engaged within NF/SGVHS is approved by the R&D Committee and its appropriate subcommittees.
  3. Ensuring there are adequate resources and administrative support, including personnel, space, equipment, and training, for the R&D Committee and its subcommittees to fulfill their responsibilities.
  4. Ensuring that adequate financial and personnel resources are provided to carry out the policies and procedures of the Human Research Protection Program (HRPP), Animal Care and Use Program (ACUP).
  5. Ensuring appropriate education and training for members of the R&D Committee and its subcommittee, the research administration staff, and other staff involved in research.
  6. Ensuring that investigators meet the requirements of Section 8. Responsibilities of the Investigator.
  7. Appointing the members of the R&D Committee following the specifications in Section 13. R&D Committee Membership.
  8. Ensuring that the Medical Center maintains a current Federal Wide Assurance (FWA) and all other required accreditations or certifications applicable to the Research Program.

6.  RESPONISBILITIES OF THE CHIEF OF STAFF (COS)

1.  Chief of Staff (COS). The (COS) and his/her office are responsible for the overall administration of the clinical operations of the NF/SGVHS. The Chief of Staff also provides oversight for all patient care, education, and research programs. In addition, the Chief of Staff plays a key role in determining the resources that are necessary to fulfill the System’s mission and vision. Specifically, the COS responsibilities to the NF/SGVHS Research Program, include:

i.  Attends the R&D Committee as an ex officio member.

ii.  Ensuring there are adequate resources and administrative support, including personnel, space, equipment, and training, for the R&D Committee and its subcommittees to fulfill their responsibilities.

iii. Consulted by the R&D Committee and IRB Chair regarding suspension of research studies, after consideration of the best interest of individual subjects.

iv. Ensuring procedures are followed in the hiring of the ACOS/R&D.

v.  Ensuring consultation with the CRADO when preparing the ACOD/R&D annual performance appraisal.

7.  RESPONSIBILITIES OF THE ACOS FOR R&D (ACOS/R&D)

The ACOS/R&D is responsible for:

  1. Notifying the investigator when a research project can be initiated. This notification occurs only after the research project has been approved by all applicable R&D Committee subcommittees, and after the final approval by the R&D Committee. The ACOS/R&D is also responsible for notifying the investigator of approval after continuing review by the R&D Committee and subcommittees.
  2. Functioning as Executive Secretary of the R&D Committee, as an ex officio member.
  3. Conducting an annual quality assurance review of publications assessing the acknowledgement of VA support and affiliation.
  4. Ensuring that information pertaining to all requests for WOC appointments for research have been appropriately justified and the appointments are in compliance with all applicable research, Human Resource Management, and other VA policies.
  5. Providing an annual quality assurance review of research employees involved in human subject research to ensure the employees are working within their scopes of practice and their privileges allowed by the facility’s by-laws and granted to them by the facility.
  6. Providing an annual quality assurance review of Cooperative Research and Development Agreements (CRADAs) and other agreements in support of the research program or specific research projects and an assessment of the impact of these agreements on the research program, when applicable.
  7. Ensuring that all minutes of the R&D Committee and its subcommittees, including those from subcommittees at VA facilities or at the affiliate, are sent to the Medical Center Director and COS for review and appropriate action.
  8. Ensuring that financial and personnel resources within the Research Service are adequate to carry out the HRPP and the ACUP.

8.  ADMINISTRATIVE OFFICER FOR R&D (AO/R&D)

The Administrative Officer for Research and Development (AO/R&D) is the individual responsible for the administrative functions of the Research Program. The AO is an ex officio member of the R&D Committee, and provides administrative support to the Committee.

9.  RESPONSIBILITIES OF THE INVESTIGATOR

The investigator is responsible for:

  1. Confirming with the applicable service chief that they have been awarded the appropriate credentials and privileges to conduct research at NF/SGVHS prior to initiating any research.
  2. Complying with all applicable personnel and other VA and NF/SGVHS requirements whether the investigator is compensated, WOC, or IPA.
  3. Obtaining the complete approval of all appropriate non-research entities and R&D Committee subcommittees, and written notification from the ACOS for R&D prior to initiating a research project.
  4. Developing a research plan that is scientifically valid; minimizes risk to human subjects, animals used in research, and personnel; and contains a sufficient description of the research including all procedures and the plan for statistical analysis, to allow the R&D Committee subcommittees to fully review the research project.
  5. Developing and implementing plans for data use, storage, and security that are consistent with VA Directive 6500, Information Security Program, and its implementing Handbooks and other legal requirements.
  6. Preparing and submitting information, annually or as otherwise required, on their research program(s) to the appropriate R&D Committee subcommittee for continuing review.
  7. Ensuring that all research proposals submitted for funding, from any source, support the mission of VHA and enhance the quality of health care delivery to Veterans at NF/SGVHS.

10.  RESPONSIBILITIES OF THE R&D COMMITTEE

1.  The R&D Committee assists the NF/SGVHS Medical Center Director in fulfilling responsibilities for the Facility’s research program. The R&D Committee is responsible for ensuring the effective operation of the research program through oversight of the R&D Committee’s subcommittees and making appropriate recommendations, including space and resource needs, to the Medical Center Director based on the Committee’s oversight and evaluation of the research program.

2.  The R&D Committee must accomplish its responsibilities through the following activities or procedures:

  1. Planning and developing broad objectives for the research program so that it supports VA’s mission;
  2. Determining the extent to which the research program has met its objectives;
  3. Overseeing all research activities for each VA facility for which it serves as the R&D Committee of record; and
  4. Reviewing all written agreements, including:
  5. Memorandum of Understanding with the University of Florida establishing the UF IRB-01 as the IRB of record for NF/SGVHS,
  6. Memorandum of Understanding with the VA Central IRB, allowing NF/SGVHS investigators to use this IRB when appropriate,
  7. Other Memorandum of Understanding and agreements that may be established and that impact research.

v.  Reviewing and evaluating the HRPP and ACUP activities, through its subcommittees, and determining that financial and personnel resources are available to carry out the HRPP and ACUP. Making recommendations to the ACOS/R and the Medical Director if gaps are found in these programs.

vi. Reviewing and evaluating all R&D subcommittees both within the VA facility and the affiliate University of Florida, Institutional Review Board (IRB-01). A summary of these reviews and evaluations must be sent to the Medical Center Director annually.

vii.  In fulfilling its responsibilities of ensuring the effective oversight of the research program and making appropriate recommendations to the Medical Center Director, including the suspension of a research study or remedial or restrictive action regarding a principal investigator, the R&D Committee needs to rely on a variety of information sources including:

a. Quality assurance activities, reports to the Committee by the ACOS for R&D, AO for R&D, or other research staff members, subcommittee reports, facility reports or activities, and other appropriate sources.

b.  Review of subcommittee activities including: